Narrow Vote but Merck's molnupiravir gets USFDA expert panel Yes

The vote was 13 for and 10 against authorization;

Published On 2021-12-01 06:38 GMT | Update On 2021-12-01 06:38 GMT

New Delhi: A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck & Co's antiviral pill to treat COVID-19.

If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency.

Merck published data last week suggesting the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.

"COVID-19 is still an emergency situation," said committee member Dr. David Hardy, who voted yes. "There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy."

The vote comes as fears about the new Omicron variant have rattled financial markets and sparked concerns about the strength of the global economic recovery as the world continues to fight the coronavirus pandemic.

Merck's oral therapy called molnupiravir, developed with Ridgeback Biotherapeutics, targets part of the virus called the RNA polymerase that has not been changed much by mutations in the Omicron variant. The pill - and a potentially more promising drug being developed by Pfizer - could become even more vital if vaccine-induced and natural immunity are threatened by the variant.

"If you look at the sequence of the of the RNA polymerase, the sequence of the Omicron variant is not very different from all of these other variants, so you would predict that it should be equally active," Merck scientist Daria Hazuda said in an interview.

Pfizer Inc's rival pill Paxlovid showed an 89% reduction in hospitalizations and deaths in its clinical trial. The FDA could consider that drug within the next few months.

The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 to recommend the agency authorize the drug after discussing concerns the drug could cause the virus to mutate as well as safety concerns about the potential for birth defects. Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy.

Several members said the reduced number of COVID-related deaths in people who received the drug in the trial convinced them to vote in favor of recommending authorization. Only one patient in the molnupiravir arm died, versus nine in the placebo group.

The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.

Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

The U.S. government has a contract to buy as many as 5 million courses of the drug at a price of $700 per course. By comparison, the U.S. paid around $20 a dose for its supply of the two-dose Pfizer/BioNTech vaccine.

Article Source : Reuters inputs

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Narrow Vote but Merck's molnupiravir gets USFDA expert panel Yes

The vote was 13 for and 10 against authorization;

Similar News

Indian pharma market registers 7.9 percent growth in July: Report

Aragen appoints Aniel Khubchandani as CEO of Development and Manufacturing Solutions business

Mounjaro, Wegovy sales in India double on month in July

Eli Lilly Gets CDSCO Panel Nod for Ixekizumab Safety Label Update

CDSCO Panel Approves New Indications for Novo Nordisk's Semaglutide, Mandates PMS Study

Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis

Axplora invests Euro 6.5 million to expand production capacity at Vizag site

NPPA Slapped Rs 9,950 Cr Penalty On Pharma Firms, Recovered Only 14.25%